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National Law Review
National Law Review
7/6/2026
Federal Circuit Affirms Nuedexta® Injunction but Vacates Zero-Dollar Bond

Federal Circuit Affirms Nuedexta® Injunction but Vacates Zero-Dollar Bond

Short summary

The Federal Circuit upheld Otsuka's patent infringement claim against Hetero Labs' generic Nuedexta, holding that dose-ratio claims should be measured using the salt forms administered in the formulation rather than free-base compounds. The court vacated the zero-dollar bond, requiring Hetero to post security for potential sales losses. This narrow pharmaceutical patent ruling may affect other dosage-ratio claims.

  • Dose-ratio claims construed to measure salt forms as administered, not free-base equivalents
  • Federal Circuit affirmed preliminary injunction blocking Hetero's generic launch
  • Court vacated zero-dollar bond; generic manufacturer must post security for lost sales

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